(73 days)
KD-5901 Fully Automatic Electronic Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is limited to 22cm-48cm.
KD-7909 Fully Automatic Electronic Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to 6.1023 inches to 9.8425 inches.
KD-5901 Fully Automatic Electronic Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is limited to 22cm-48cm.
KD-7909 Fully Automatic Electronic Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to 6.1023 inches to 9.8425 inches.
KD-5901 and KD-7909 are all designed and manufactured according to ANSI/AAMI SP10--manual, electronic or automated sphygmanometers.
The operational principle of KD-5901 and KD-7909 are based on oscillometric and silicon integrate pressure sensor technology, the result will be shown on a LCD with an electronic interface module, the result can also be classified and displayed by the function of blood pressure classification indicator, the memory capability is 60 times. If any irregular heartbeat is detected, it can be shown on the LCD. KD-5901 also has a voice function.
Here's an analysis of the provided text regarding the acceptance criteria and study for the KD-5901 and KD-7909 Fully Automatic Electronic Blood Pressure Monitors:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly define specific numerical acceptance criteria (e.g., accuracy ranges for blood pressure measurements) or report the device's performance against such criteria. Instead, it states that the devices conform to recognized standards. These standards implicitly contain the acceptance criteria for performance.
Implicit Acceptance Criteria (from conformity to standards):
| Acceptance Criteria | Reported Device Performance |
|---|---|
| IEC 60601-1 (General Requirements for Safety) | Conforms |
| IEC 60601-1-2 (Electromagnetic Compatibility) | Conforms |
| AAMI SP10:2002 (Manual, electronic or automated sphygmomanometers) | Conforms |
| AAMI/ANSI SP10:2002/A1:2003 (Amendment 1 to AAMI SP10:2002) | Conforms |
| AAMI/ANSI SP10:2002/A2:2006 (Amendment 2 to AAMI SP10:2002) | Conforms |
Note: To find the specific numerical acceptance criteria for blood pressure measurement accuracy, one would need to consult the AAMI SP10 standard itself. The submission only states that the devices conform to this standard.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size (number of subjects/measurements) used for the test set or the data provenance (e.g., country of origin, retrospective/prospective nature of the data). It broadly states that "the test in this submission provides demonstration that these small differences do not raise any new questions of safety and effectiveness," referring to performance testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not provide information on the number of experts used or their qualifications for establishing ground truth. For blood pressure monitors, ground truth is typically established by trained technicians or clinicians using a reference standard device (like a mercury sphygmomanometer) following a specific protocol.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not describe a multi-reader multi-case (MRMC) comparative effectiveness study or any effect size related to human readers improving with or without AI assistance. This type of study is more common for diagnostic imaging AI devices, rather than blood pressure monitors.
6. Standalone Performance Study
The document implies that a standalone performance study was conducted in the sense that the devices were tested for their conformity to the AAMI SP10 standard. AAMI SP10 outlines methodologies for testing the accuracy of automated sphygmomanometers against a reference standard. Therefore, the "algorithm only" (which in this case refers to the device's internal measurement algorithm) performance was assessed.
7. Type of Ground Truth Used
The ground truth used for performance validation would be established by measurements from a reference standard device (e.g., a mercury sphygmomanometer or another validated oscillometric device) in accordance with the AAMI SP10 standard. The document doesn't explicitly state "reference standard device" but its conformity to AAMI SP10 implies this methodology.
8. Sample Size for the Training Set
The document does not provide any information regarding a training set sample size. Since this device likely uses a pre-programmed oscillometric algorithm based on principles rather than a learning-based AI model, there wouldn't typically be a "training set" in the machine learning sense. The device's algorithm would be developed and validated against a representative population, consistent with the AAMI SP10 standard.
9. How Ground Truth for the Training Set Was Established
As there is no mention of a "training set" in the context of a machine learning model, this information is not applicable/not provided in the document. The oscillometric algorithm itself is based on established physiological principles and empirical validation data as part of its development, conforming to standards like AAMI SP10.
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).